A presentation on working as a manufacturing scientist in a company specialising in provision of clinical trials (c) Pharmaceutical Profiles and Steve Coney, 2009

1. Bridging the Gap
From Medical Biochemistry to Clinical Trials
Steve Coney – Manufacturing Scientist
Pharmaceutical Profiles Ltd
12 March 2009
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2. Who are Pharmaceutical Profiles?
• Nottingham University spin out
– 1990, School of Pharmaceutical Sciences
• Unique and differentiated technology
• Approximately 100 people
– 20,000 ft2 Ruddington, Nottingham
• >30 clinical studies per year
– Global customer base
– 65% USA, 25% Europe, 10% Japan
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3. How do we make our money?
Clinical investigation of bioavailability issues
• Application of novel technologies and
methodologies to understand how to build an
optimal drug formulation for man
– EnterionTM, iv MicroTracer PK, pharmacoscintigraphy
Rapid evaluation of new formulations in man
• Integrated manufacturing and clinical evaluation to
enable rapid evaluation and validation of test
formulations
– Oral, inhaled, intravenous, and intranasal routes of delivery
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4. The Enterion Capsule
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5. What do we do?
Manufacturing Clinical
GCP Facility, 30 beds
GMP Facility
Phase 0 microdosing
Formulation R&D
IV PK & Metabolism
Analytical R&D
Phase I
Radiolabelling
Phase IIa POC
CT manufacture
Pharmacoscintigraphy
Remote controlled
Formulation validation
Targeted within GI
Gastric emptying/motility
Multiple dosage forms
Lung / nasal deposition
Imaging
Enterion TM
Enterion Imaging
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6. Who do we work for?
• Worked with the majority of top 30
pharma companies
• Over 250 biotechnology companies
• Greater than 30 marketed oral drugs
• >50 oral drugs currently in development
• 16 of the top 100 selling drugs
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7. What can we do?
•Radiolabelled egg
Enterion capsules
•
Routes of
administration
•Radiolabelled drink
Tablets
•
• Oral
•Nasal sprays
Capsules • Intravenous
•
• Inhaled
•pMDIs
• Intranasal
Solutions
•
• Rectal
•Powder inhalers
• Intravaginal
Aseptic manipulations
•
• Dermal
•Nebulised doses
Ointments & creams
•
•14C-microdoses
Neutron Activation
•
•Encapsulation
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8. Clinical Trials – an Overview
• Four main stages:
– Phase I Initial human testing - safety
– Phase II Dose finalisation
– Phase III Therapeutic trials
– Phase IV Post-marketing safety monitoring
• Also one further stage:
– Phase 0 “microdosing”
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9. Where does PP fit in?
• Mainly Phases 0, I and II (although some III)
• Market leader in Phase 0 IV 14C-microdosing
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10. About Me
• Graduated 2006 BSc(hons) Medical Biochemistry
• June 2006-April 2007 UHL Nursing Auxilliary
• Joined PP April 2007
• Married June 2007
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11. What do I do?
• Manufacturing Scientist
• Prepare Investigational Medicinal Products (IMPs)
• Manage supplies
• Perform in vitro experiments
• Trained to handle radioactive materials
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12. How do you get into Clinical Trials?
• Apply for jobs
• Gain experience in the Pharmaceutical/Food
Industry
• Many roles requiring Bioscience graduates
• Volunteer!!
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13. Any Questions?
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